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Program Overview & Value Proposition

Program Overview & Value Proposition. Content. Objective Background Chronology Benefits Medical Device Industry Medical Device Industry OEMs Medical Device Industry Suppliers Scope of Project Critical Process Areas of Interest Existing PRI Processes and Products Process Map

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Program Overview & Value Proposition

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  1. Program Overview & Value Proposition

  2. Content • Objective • Background • Chronology • Benefits • Medical Device Industry • Medical Device Industry OEMs • Medical Device Industry Suppliers • Scope of Project • Critical Process Areas of Interest • Existing PRI Processes and Products • Process Map • Timeline – High Level Summary • 2013 Meetings & Details • Program Development Activity (Outside of Roundtable Meetings) • Requests to Medical Device Industry Stakeholders • Program Risk Analysis • Confidentiality of Information • Case Studies • Aerospace (Airline Passenger Safety Trends) • Aerospace (Nadcap Subscriber Critical Process Escapes) • Transportation & Power Generation (OEM) • Medical Device (Electronic Circuits Hypothetical) • Financials • Cost Structure • Template for Cost/Benefit Calculation

  3. Objective To demonstrate to the medical device industry the value of creating an industry managed supply chain oversight program (MedAccred) that will reduce risk to patient safety, assure quality products and compliance with requirements as they apply to critical processes

  4. Background • Increased number of recalls attributed to supplier quality issues • Overall increased interest in outsourcing and globalization of the supply chain, thereby increasing the challenge of oversight • Purchasing controls is one of the top ten cited FDA 483 observations for medical device quality system violations • Purchasing controls has been the target of several enforcement actions (warning letters, consent decrees)

  5. Chronology

  6. Next Steps • Increase participation and commitment from the Medical Device Manufacturers • Increase participation from Suppliers who provide a Critical Manufacturing Process • Conduct proof of concept (PoC) audits in four technology areas (Electronic Circuits, Electronics – Cable & Harnesses, Welding, Heat Treatment) – 3 completed YTD • Task Groups to continue audit checklist development, auditor recruitment, etc. • Continue to conduct regular Management Council face to face meetings and bi-weekly conference calls to provide status updates on sub-team and Task Group activity and continue program development momentum • Continue dialogue with CDRH and FDA – Commissioners Level • Signature of Subscriber Agreements

  7. Benefits to Medical Device Industry • Promotes a philosophy of continuous improvement and a culture of patient safety and qualityfor all participants • Enhances compliance and quality management system effectiveness throughout the industry • Promotes best practices to assure patient safety and quality • Promotes application of industry and technical standards/practices • Provides an opportunity for collaborationbetween suppliers and OEMs • Improves visibility of industry requirements to sub-tier suppliers Similar program in aerospace industry has 20 year history of successful performance and regulatory acceptance

  8. Benefits to Medical Device Industry (cont.) • Promotes least burdensome approach by reducing redundant process audits by multiple customers • Enables reallocation of resources to other areas requiring attention • Provides real-timeand consistent visibility of supply chain quality • Aligns with FDA’s “Case for Quality” strategic initiative

  9. Benefits to Medical Device Industry OEMs • Establish stringent industry consensus audit criteria based on industry and specific OEM requirements that ensure compliance and quality of devices, reduce the risk to patient safety and will satisfy the requirements of all participants • Conduct in-depth special process audits that are compliant and consistent to accepted industry/technical standards and conducted by industry recognized and approved Subject Matter Experts. • Covers 3 areas: • Assess effectiveness of suppliers’ QMS at the special process level; • Audits based on robust core and OEM-specific checklists; • Process-focused Product Audits

  10. Benefits to Medical Device Industry OEMs (cont.) • Provides greater visibility of the supply chain to all levels and sub-tiers that provide critical processes, consistent with regulatory requirements (e.g. FDA, ISO 13485, MDD, etc.) • Identify and reducerisk of exposure to lower-quality suppliers and reduction of costly recalls • Provides early warning notification to OEMs of supply chain quality issues • Provides complete visibility of audit results and corrective actionstaken in a secure and retrievable format • Program reduces cost of non-quality • Program reduces cost of compliance

  11. Benefits to Medical Device Industry OEMs (cont.) • Program freesup OEM resources to focus on supplier development opportunities and/or problem area resolution • Improves flow down of OEM requirements to sub-tier suppliers • Makes the supplier selection process more efficient • Globalsupply chain visibility through a web based system to support and improve efficiency in industry managed auditing and accreditation system (eAuditNet). • Supports procurement to identify accredited suppliers (Qualified Supplier List) • Supports supplier risk management activity • Shared pool of trained, recognized and approved subject matter experts among OEMs

  12. Benefits to Medical Device Industry Suppliers • Provides consistent/standardized critical process audits accepted by the medical device industry resulting in fewer redundant onsite audits by multiple OEMs • Can use accreditationto increase client-base and opportunities across the medical device industry • Enhances the supplier’s compliancestatus • Medical device industry-accepted and consistent technical requirements leading to process discipline, greater operational efficiency and continuous improvement resulting in higher quality and loweroverall cost.

  13. Benefits to Medical Device Industry Suppliers (cont.) • Helps suppliers develop a structured approach to special process and product • Opportunity to participate in development of audit criteria and the accreditation program • 85% of suppliers report quality improvements after accreditation, including reducing scrap rates, reworks, escapes and defective products (from aerospace survey data)

  14. Critical Process Areas of Interest • Casting/Forging • Chemical Processing • Cleaning • Coatings • Electronics • Displays • Electronic Circuits - PCBAs**** • Power sources/supplies** • Cable & Harnesses*** • Fluidics • Heat Treatment** • Machining • Laser Etch • Material Testing Laboratories • Measurement/Inspection • Non-Destructive Testing • Optics • Packaging • Sterile • Raw Materials • Re-agent • Resins • Composites • Injection Molding • Sterilization**** • Software* • Hosted Services • Welding* KEY: BOLD PRI currently has checklists addressing these Critical Process/Product areas BLUE Active Task Groups as of February 2014 * Number of votes received by 22Mar13 Dallas Roundtable participants for conducting Proof of Concept audits

  15. Existing Nadcap Processes and Products Special Processes Systems & Products Non-Destructive Testing Coatings Castings & Forgings Aerospace Quality Systems Electronics Composites Fluid Distribution Systems Welding Non-Conventional Machining Future Processes Elastomer Seals Sealants Chemical Processing Conventional Machining as a Special Process Raw Materials Measurement & Inspection Materials Testing Laboratories Non Metallic Materials Testing Heat Treating Surface Enhancement Non Metallic Materials Manufacturing The Medical Device Industry has expressed interest in these Critical Processes and Products

  16. MMC Meeting (Pittsburgh, PA)Wed 9/17/14 MMC Meeting (Pittsburgh, PA)Wed 12/3/14 MMC Meeting (Pittsburgh, PA)Wed 8/28/13 MMC Meeting (Minneapolis, MN)Thu 10/31/13 MMC Meeting (Pittsburgh, PA)Thu 12/5/13 MMC Meeting (Anaheim, CA)Wed 2/12/14 MMC Meeting (Cincinnati, OH)Mon 5/5/14 4th Quarter 6JAN14 2nd Quarter 3rd Quarter 4th Quarter StartWed 8/28/13 FinishFri 12/19/14 Internal OEM Buy-inWed 8/28/13 - Fri 1/3/14 (ASK) OEMs issue supplier mandates as applicableTue 4/1/14 - Fri 12/19/14 (ASK) Assemble List of SuppliersWed 8/28/13 - Fri 1/31/14 Rally external stakeholders for Program buy-inMon 2/3/14 - Thu 10/23/14 • (ASK) OEMs sign Subscriber Agreements (Tue 10/1/13 - Fri 1/31/14) European and Asian OEM engagementTue 4/1/14 - Fri 12/19/14 Conduct PoC AuditsWed 8/28/13 - Fri 3/28/14 Review PoC Audit Results for ValueWed 8/28/13 - Fri 3/28/14 Define Auditor Requirements/HiringMon 11/4/13 - Fri 6/27/14 Approach Industry AssociationsMon 11/4/13 - Fri 12/19/14 Draft Program DocumentsWed 8/28/13 - Fri 1/3/14 Approach broader Supply baseMon 1/6/14 - Fri 12/19/14 Approach and gain buy-in from Regulatory Agencies Mon 9/30/13 - Fri 6/27/14 Validate SoftwareWed 8/28/13 - Fri 6/27/14 Configure eAuditNet to support MedAccredWed 8/28/13 - Fri 6/27/14 FDA Meetings (CDRH and OGROP)Mon 12/2/13 - Mon 3/31/14 Release MedAccred Program Document (PD1300)Wed 1/1/14 - Mon 3/31/14 Launch Supplier Support CommitteeTue 4/1/14 Seek FDA follow-up meeting/progress report Tue 4/1/14 - Thu 5/1/14 MedAccred Development Plan (Dec 2013 – Q4 2014) Key OEM Responsibility PRI Responsibility Joint Responsibility

  17. MMC Meeting (Pittsburgh, PA)Wed 9/17/14 MMC Meeting (Pittsburgh, PA)Wed 12/3/14 MMC Meeting (Cincinnati, OH)Mon 5/5/14 MMC Meeting (Anaheim, CA)Wed 2/12/14 MMC Meeting (Minneapolis, MN)Thu 10/31/13 MMC Meeting (Pittsburgh, PA)Thu 12/5/13 4th Quarter 6JAN14 2nd Quarter 3rd Quarter 4th Quarter 1st Quarter StartWed 8/21/13 FinishFri 2/27/15 (STL) Checklist developmentWed 8/21/13 - Fri 3/28/14 Pilot Audit (STL) Checklist refinementFri 5/2/14 - Tue 9/30/14 (STL) Pilot audit of revised checklistsWed 10/1/14 - Fri 12/19/14 (WLD) Ongoing checklist reviewWed 8/21/13 - Fri 1/31/14 (STL) Define auditor requirements/hiringFri 5/2/14 - Tue 9/30/14 (WLD) Define auditor requirements/hiringWed 8/21/13 - Fri 1/31/14 (WLD) Pilot audit of revised checklistsMon 2/3/14 - Fri 6/20/14 (WLD) Release checklists for supplier preparationMon 6/23/14 - Fri 11/7/14 PoC (EC) Checklist reviewMon 9/30/13 - Fri 2/14/14 (EC) Define auditor requirements/hiringMon 9/30/13 - Fri 2/14/14 (EC) Pilot audit of revised checklistsMon 2/17/14 - Mon 7/7/14 (EC) Release checklists for supplier preparationTue 7/8/14 - Mon 11/24/14 PoC (HT) Ongoing checklist reviewMon 10/21/13 - Tue 3/4/14 (HT) Define auditor requirements/hiringMon 10/21/13 - Tue 3/4/14 (HT) Pilot audit of revised checklistsWed 3/5/14 - Mon 8/4/14 (HT) Release checklists for supplier preparationWed 8/6/14 - Fri 12/19/14 PoC (CH) Ongoing checklist reviewMon 3/3/14 - Wed 7/9/14 (CH) Define auditor requirements/hiring (CH) Pilot audit of revised checklistsThu 7/10/14 - Wed 11/26/14 (CH) Release checklists for supplier preparationThu 11/27/14 - Fri 2/27/15 Develop Task Group Operating Procedures as applicableTue 10/1/13 - Mon 9/15/14 (ASK) OEMs issue supplier mandates as applicableTue 4/1/14 Launch Supplier Support CommitteeTue 4/1/14 (ASK) OEMs sign Subscriber AgreementsMon 1/6/14 - Fri 1/31/14 FDA Meetings (CDRH and OGROP)Mon 12/2/13 - Mon 3/31/14 Task Group Development Plan (Dec 2013 – Q4 2014) Key Electronic Circuits - PCBA Electronics – C & H Heat Treating Sterilization Welding

  18. Program Risk Analysis • Risks of developing a program/not doing it right • Not timely • No critical mass • Proof of Concept audits not showing much • Cost could go up without critical mass • Risks to implementing a program • Will find suppliers that aren’t capable – increased exposure • Could mean more work for OEM – short term stretch on resources • Finding enough/the right SMEs to conduct audits • Agency acknowledgement • OEM may still have to conduct special process audits

  19. Confidentiality of Information Addressed in Nadcap Operating Procedures (NOP): • NOP-001 describes the Nadcap program “These Operating Procedures shall govern the operations of the Nadcap Program. This document establishes the policies for how Nadcap shall meet the requirements defined in SAE AS7003. Nadcap Management Council (NMC) and all Nadcap Task Groups and committees shall operate in accordance with these procedures and all referenced documents.” • NOP-002 describes the roles and functions around Task Groups.

  20. Confidentiality of Information (cont.) eAuditNet security features: • eAuditNet implements operating procedures: • Each Company has one (or more) administrator(s) who are verified by PRI before any other users can be associated with that Company • Each user has unique credentials, and is only associated with a Company by that Company's administrator(s) • Each user can only access audits/functions relevant to their company and roles • eAuditNet uses standard IT security best practices: • All eAuditNet/program data is delivered over Secure Socket Layer (‘https’) • All system activity is logged • Audit data is stored behind multiple firewalls, and physical safeguards are in place • PRI and SAE have regular information security audits: • PCI compliance • External penetration testing, etc

  21. Case Studies • Aerospace (Airline Passenger Safety Trends) • Aerospace (Nadcap OEM – Critical Process Escapes) • Transportation & Power Generation (OEM) • Medical Device (Electronic Circuits Hypothetical)

  22. Aerospace (Airline Passenger Safety Trends) *Data from Aviation Safety Network and NTSB

  23. Since March 20, 1997, aircraft -10 or more seats scheduled passenger service have been operated under 14 CFR 121. Definitions of NTSB Classifications: Major- an accident in which any of three conditions is met:     a Part 121 aircraft was destroyed, or  there were multiple fatalities, or  there was one fatality and a Part 121 aircraft was substantially damaged.  Serious- an accident in which at least one of two conditions is met:     there was one fatality without substantial damage to a Part 121 aircraft, or there was at least one serious injury and a Part 121 aircraft was substantially damaged.  Injury- a nonfatal accident with at least one serious injury and without substantial damage to a Part 121 aircraft. Damage- an accident in which no person was killed or seriously injured, but in which any aircraft was substantially damaged. *Data from Aviation Safety Network and NTSB

  24. Aerospace OEM - Critical Process Escapes 78% decrease * An escape is where defective product has been shipped to the customer prior to being identified as faulty

  25. Transportation & Power Generation (TPG) Program – Fastener Example • Event: OEM experienced a product escape due to a faulty fastener and were forced to make an expensive repair • Included in OEM Recourse: Requested a PRI NDT audit for their fastener supplier • TPG Audit Results: NDT audit uncovered cracks not found during initial inspection and process control violations that would have prevented the cracks • Pre-TPG Program: Focus was on certifying the component (product-centric)

  26. Medical Device Quality-Related Product Recall (Hypothetical) 2010: FDA issues a Class II recall on an Automated External Defibrillator ¹. Root cause: Printed Circuit Board Assembly (Electronic Circuits) Trautman, K. (2010). Purchasing Controls – Background & Examples. Retrieved November 02, 2012, from FDANews.com

  27. Medical Device Quality Related Product Recall (Hypothetical) (cont.) How would Nadcap address this issue? • Root cause: • Printed Circuit Board Assembly (Electronic Circuits) • Supplier has incorrectly applied solder flux • Ineffective cleaning • Nadcap process compliance is used as a preventative measure: • AC7120 Revision B – audit criteria for circuit card assembly • 17.1 Reflow Soldering • 17.1.14.C Are soldering defects including solder joint touchup identified, recorded and addressed in a continuous improvement plan? • 17.1.15.C Is the cleaning method being used as per the procedure and is the maximum time permitted between reflow and cleaning being observed? • Audit Note: Maximum allowed time of 8 hours unless otherwise specified by customer or manufacturer’s • recommendation. • 20 Coatings and Encapsulation • 20.1.C Is there objective evidence of cleanliness verification?

  28. Cost Structure • Subscription Fees • Supplier Audit Pricing (per-audit fee including travel costs) Based on current auditor daily fee of $420 per day. Will be increased as Auditor fees and travel costs increase in subsequent years. * A travel surcharge will be added (expected to be between USD 1000 and 2000) for Asia-Pacific and South American audits, and for ITAR/EAR audits outside of North America

  29. OEM Cost/Benefit Template • What number of Critical Process Audits currently performing? • How many can be eliminated? • What is the cost to conduct these audits? • Travel/Time savings? • Can the QMS audits currently being conducted by OEMs be reduced? • cGMP compliance • Intangibles • Draw from entire med-tech industry expertise • OEM experts could observe audits conducted by Subject Matter Experts

  30. Upcoming MMC Meetings - 2014 Next Teleconference • 7 March 2014, 11:00 EST Face to Face • 5 May 2014, Cincinnati, OH

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